Clinical Trial of Radiotherapy in Treating Primary Hepatocellular Carcinoma

NCT03614546 | Unknown

• 1 other identifier: HCC-RT-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The subjects of primary hepatocellular carcinoma diagnosed pathologically or clinically will be grouped according to the size, location, number and function of the liver, and respectively received Intensity-modulated Radiation Therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), Transarterial chemoembolization (TACE) or surgery.

Conditions

Primary Hepatocellular Carcinoma

Keywords

primary hepatocellular carcinoma; radiotherapy; transarterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• Overall Survival(OS)

  The time of patients from randomization to death caused by any cause.

  up to 5 years

Secondary Outcomes (4)

• Disease control rate(DCR)

  up to 5 years

• Progression free survival (PFS)

  up to 5 years

• Incidence of adverse events

  up to 5 years

• Minimal volume of liver free from radiation

  up to 5 years

Study Arms (7)

A（surgery） group

OTHER

Hepatectomy

Procedure: Hepatectomy

B1（SBRT） group

EXPERIMENTAL

Stereotactic Body Radiation Therapy(SBRT), 40-55Gy/5-6F

Radiation: SBRT

B2a（TACE+ IMRT ） group

EXPERIMENTAL

First，treat with intensity modulated radiation therapy (IMRT),50Gy/25F/5W, 4 weeks after IMRT，treat with transcatheter arterial chemoembolization（TACE） 2-4 times

Radiation: IMRT; Procedure: TACE

B2b（TACE+ IMRT ） group

EXPERIMENTAL

First，treat with transcatheter arterial chemoembolization（TACE） 2-4 times，4 weeks after TACE，treat with intensity modulated radiation therapy (IMRT),50Gy/25F/5W

Radiation: IMRT; Procedure: TACE

C1（SBRT） group

EXPERIMENTAL

Stereotactic Body Radiation Therapy, 40-55Gy/5-6F

Radiation: SBRT

C2a（TACE+ IMRT ） group

EXPERIMENTAL

First，treat with intensity modulated radiation therapy (IMRT),50Gy/25F/5W, 4 weeks after IMRT，treat with transcatheter arterial chemoembolization（TACE） 2-4 times

Radiation: IMRT; Procedure: TACE

C2b（TACE+ IMRT ） group

EXPERIMENTAL

First，treat with transcatheter arterial chemoembolization（TACE） 2-4 times，4 weeks after TACE，treat with intensity modulated radiation therapy (IMRT),50Gy/25F/5W

Radiation: IMRT; Procedure: TACE

Interventions

SBRT RADIATION

Stereotactic Body Radiation Therapy (SBRT)

B1（SBRT） group; C1（SBRT） group

IMRT RADIATION

Intensity-modulated Radiation Therapy (IMRT)

B2a（TACE+ IMRT ） group; B2b（TACE+ IMRT ） group; C2a（TACE+ IMRT ） group; C2b（TACE+ IMRT ） group

Hepatectomy PROCEDURE

Hepatectomy

A（surgery） group

TACE PROCEDURE

transarterial chemoembolization (TACE)

B2a（TACE+ IMRT ） group; B2b（TACE+ IMRT ） group; C2a（TACE+ IMRT ） group; C2b（TACE+ IMRT ） group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnosis criteria of primary hepatocellular carcinoma: (1) primary hepatocellular carcinoma diagnosed by histology or cytology; (2) primary hepatocellular carcinoma diagnosed clinically (referring to the standard of diagnosis and treatment of primary hepatocellular carcinoma, version 2017);
• Stage Ia-IIIa disease (referring to the standard of diagnosis and treatment of primary hepatocellular carcinoma, version 2017).
• Child-Pugh score class A or B without encephalopathy;
• Age between 18-80 years old;
• At least one measurable lesion according to the 1.1 version of response evaluation criteria in solid tumors (RECIST).
• ECOG(Eastern Cooperative Oncology Group) performance status of 0-2 at enrollment(subjects with ECOG performance status of 2 did not deteriorate in the last 2 weeks).
• Written informed consent for the trial.
• Be Willing and able to comply with planned visits, treatment plans, laboratory tests and other test procedures.
• Have a life expectancy greater than 3 months judged by investigators；

You may not qualify if:

• \. History of upper abdominal radiotherapy; 2. History of liver transplantation; 3. Abnormal laboratory results as follows:
• abnormal hematology results, including hemoglobin less than 8.5 g/dL (no blood transfusion within 14 days before); neutrophils less than 1.5×109 /L or platelets less than 60×109 /L (no blood transfusion or growth factor was used within 7 days before);
• abnormal liver function: total bilirubin \>3×upper limit of normal (ULN); aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 5×ULN;
• abnormal renal function: serum creatinine \>1.5×ULN, or creatinine clearance rate (CrCl) \< 60 mL/min according to Cockcroft-Gault formula.
• international normalized ratio (INR) \> 2.3 (according to the revised Child-Pugh grading Guide);
• the calibration values of potassium, sodium, magnesium or calcium not within the normal range, and have clinical significance according to the judgment of the primary investigator.
• \. History of other cancers besides primary hepatocellular carcinoma, with the exception of cured non-melanoma skin cancer, in situ cervical cancer, or other cancers received cured treatment and showed no signs of disease in at least 3 years.
• \. Metastases to central nervous system (CNS) or brain; 6. Significant gastrointestinal bleeding occurred within 4 weeks before entering the trial.
• \. Cardiac dysfunction as demonstrated by any of the following conditions:
• recent echocardiography revealed a left ventricular ejection fraction \< 45%.
• severe arrhythmia;
• unstable angina pectoris;
• New York Heart Association III and IV congestive heart failure;
• myocardial infarction occurred in the last 12 months before admission.
• pericardial effusion; 8. Uncontrolled hypertension after standard treatment (blood pressure not stably below 150/90 mmHg) 9. Known human immunodeficiency virus (HIV) infection; 10. Pregnant or during lactation period, or is fertile male and female who is not willing or unable to take birth control/contraception to prevent pregnancy during the period between 2 weeks before radiation and 1 month after radiation; 11. Substance abuse, other acute or chronic physical or mental illness or abnormal laboratory examination that might increase the risk of participation judged by investigator.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• peiguo cao, doctor

  The Third Xiangya Hospital, Central South University

  STUDY CHAIR

Central Study Contacts

xi zhang, doctor

CONTACT

86-13787318097; flash_z@126.com

zewen song, doctor

CONTACT

86-18374800202; thomasze2007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of oncology department

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 3, 2018
• Study Start: October 10, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2021
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)